Clinical Trials Logo
  1. Home
  2. Head and Neck Neoplasms
  3. NCT00993512

Safety Study of Amphinex Based Photochemical Internalisation (PCI) of Bleomycin in Patients With Cutaneous Cancer

Head and Neck Neoplasms Clinical Trial

Official title:
Phase I, Dose-escalating Study to Evaluate Safety and Tolerance of Amphinex Based Photochemical Internalisation (PCI) of Bleomycin in Patients With Local Recurrence or Advanced/Metastatic, Cutaneous or Sub-cutaneous Malignancies

Clinical Trial Summary

This study is an open, non- randomized, phase I, dose-escalating study to evaluate the safety and tolerance of Amphinex based PCI of bleomycin in patients with local recurrent or advanced/metastatic, cutaneous or sub-cutaneous malignancies.

Clinical Trial Description

Eligible patients will be included in cohorts of 3 patients. The initial starting dose for Amphinex will be given 4 days prior to the fixed dose of bleomycin administered by intravenous infusion. The illumination, with red light (laser 652 nm), to the tumour surface and a margin of 2-3 mm outside the tumour surface, will be performed after bleomycin administration.

There will be no comparative procedure in this study. Dose escalation will proceed according to a modification of Simon's accelerated titration design. The number of patients recruited depends on the DLT experienced. A total of 6 patients will be included at each dose level if no more than 1 patient experiences DLT.

Additional cohorts may be added pending the outcome of the previous cohorts and discussions between the investigators and the Sponsor. The primary goal of the study is to assess the safety and tolerance of the Amphinex and determine the maximal tolerated dose (MTD) of Amphinex as a PCI therapy in combination with bleomycin treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00993512
Study type Interventional
Source PCI Biotech AS
Contact
Status Completed
Phase Phase 1
Start date August 2009
Completion date May 2011
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05980598 - TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma Phase 2
Completed NCT02548377 - Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial N/A
Active, not recruiting NCT02229656 - Olaparib and Radiotherapy in Head and Neck Cancer Phase 1
Not yet recruiting NCT06347185 - Simultaneous Care in Recurrent and/or Metastatic Head and Neck Cancer: the SupCare Study N/A
Not yet recruiting NCT06289049 - Heavy Strength Training in Head and Neck Cancer Survivors Phase 2
Terminated NCT02975739 - Feasibility of Holmium-166 Micro Brachytherapy in Head and Neck Tumors N/A
Recruiting NCT00982436 - Neoadjuvant Cisplatin/Docetaxel (CDDP/TXT) and Chemoradiation for Head and Neck Cancer Phase 1/Phase 2
Completed NCT01025518 - DAHANCA 25A: Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients N/A
Active, not recruiting NCT00248235 - Resistance Exercise Training for the Shoulder and Neck Following Surgery for Head and Neck Cancer Phase 2/Phase 3
Completed NCT00135161 - Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer Phase 1
Terminated NCT00073450 - Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530) Phase 2
Not yet recruiting NCT06458517 - Evaluation of Two Methods of Administration of Photobiomodulation in the Context of the Prevention and Treatment of Mucositis Induced by Radiotherapy, During the Treatment of Head and Neck Cancers N/A
Completed NCT05269342 - Nurse-led Exercise Improves Shoulder Pain, Shoulder Disability, and Quality of Life in Head and Neck Cancer N/A
Recruiting NCT05544136 - A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer Phase 2
Terminated NCT03286972 - PET/MRI to Enhance Precision Guidance in Head and Neck Radiation Treatment Planning
Recruiting NCT04435938 - A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck Phase 2
Recruiting NCT03975465 - EMST and Swallowing in Long-Term Survivors of HNCA N/A
Recruiting NCT03678649 - A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC Phase 2
Completed NCT03292250 - Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)] Phase 2
Completed NCT06446570 - Phase II Study of Durvalumab(MEDI4736) + Tremelimumab in Pulmonary Sarcomatoid Carcinoma Phase 2